Nitrofurantoin

Product NDC: 68071-3569
Requested package NDC: 68071-3569-4
11-digit product format: 680713569
Labeler code: 68071
Product ID: 68071-3569_59690232-7003-0bc1-e063-6294a90a73a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrofurantoin (monohydrate/macrocrystals)
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA217357
Marketing category: ANDA
Marketing start: 2023-09-14
Substance: NITROFURANTOIN MONOHYDRATE; NITROFURANTOIN
Active strength: 75; 25 mg/1; mg/1
Pharmacologic classes: Nitrofuran Antibacterial [EPC], Nitrofuran Antibacterial [EPC], Nitrofurans [CS], Nitrofurans [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE	75MG;25MG	CAPSULE / ORAL	AB		2023-07-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A217357-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217357-001	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	75MG;25MG	CAPSULE / ORAL	AB	2023-07-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217357-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217357-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217357-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217357-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217357-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217357-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217357-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217357-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217357-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217357-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217357-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217357-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217357-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217357-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217357-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217357-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217357-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217357-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217357-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217357-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217357-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217357-001	AB	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217357-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Nitrofurantoin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROFURANTOIN MONOHYDRATE	75 mg/1
NITROFURANTOIN	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
E1QI2CQQ1I	Internal UNII lookup
927AH8112L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1648755	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
10e2503d-a250-996f-e063-6294a90abd61	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d02ec8bb-3b28-9b95-8719-8dbb1a2ec5cf	Product name	6	20251106
f6207266-e92b-4b5b-a91b-4af4215c9542	Product name	6	20240813
e31776f7-6119-9577-e170-5b569993276e	Product name	5	20240320
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3569-2	Nitrofurantoin	20 in 1 BOTTLE	CAPSULE	20		2
68071-3569-4	Nitrofurantoin	14 in 1 BOTTLE	CAPSULE	14		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3569	NITROFURANTOIN (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)) CAPSULE [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, 2 package rows	20240301_10e2503d-a250-996f-e063-6294a90abd61.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	REMEDYREPACK INC.	4553ccc1-0bad-4c75-aae2-1a1c87bc8db0	2026-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	REMEDYREPACK INC.	e55f3dc2-c754-4550-a2c0-c304471a8791	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	10e2503d-a250-996f-e063-6294a90abd61	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357 ndc (package): 68071-3569-4 ndc (product): 68071-3569 ndc11 (package): 68071356904
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	BluePoint Laboratories	ea28d766-d6e6-43d2-8282-dc78a0381057	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Coupler LLC	513b514f-6e79-f187-e063-6394a90a07dc	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Coupler LLC	5087f071-5ef4-753e-e063-6294a90afb8d	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Major Pharmaceuticals	85c7d4ee-99f5-4324-a5fa-601c2fe664ab	2026-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Redpharm Drug	18987b15-6554-6b55-e063-6294a90a58d4	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Preferred Pharmaceuticals Inc.	11e8f91c-5712-4267-9956-e619d081d1f4	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NuCare Pharmaceuticals,Inc.	155c8d68-576e-f85c-e063-6294a90ada4b	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Bryant Ranch Prepack	63a4b367-bf4b-4b5f-b3e9-394ba307886d	2025-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Proficient Rx LP	f49f586a-79f0-4731-97f9-9aeb0839ece5	2024-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	NorthStar RxLLC	d1c778b5-70df-4312-976b-d0bca0cb602a	2023-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357
Nitrofurantoin (monohydrate/macrocrystals)	NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)	Lifestar Pharma LLC	35c0a6d8-ff85-4d9b-9ad3-ae20808119dd	2023-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217357 application number: ANDA217357

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
E1QI2CQQ1I	NITROFURANTOIN MONOHYDRATE	17140-81-7	NITROFURANTOIN MONOHYDRATE
927AH8112L	NITROFURANTOIN	67-20-9	NITROFURANTOIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1648755	nitrofurantoin macrocrystals 25 MG / nitrofurantoin monohydrate 75 MG Oral Capsule	PSN	10e2503d-a250-996f-e063-6294a90abd61	2
1648755	nitrofurantoin, macrocrystals 25 MG / nitrofurantoin, monohydrate 75 MG Oral Capsule	SCD	10e2503d-a250-996f-e063-6294a90abd61	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3569-4	68071356904	14 CAPSULE in 1 BOTTLE (68071-3569-4)	14 capsule	2024-02-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrofurantoin Capsules, USP (monohydrate/macrocrystals) Rx Only	NuCare Pharmaceuticals,Inc.	2026-08-19	HUMAN PRESCRIPTION DRUG LABEL	3